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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name forceps, biopsy, electric
510(k) Number K932266
Device Name SYMBIOSIS DISPOS GASTRO BIOPSY FORCEPS W/REUSE HAN
Applicant
SYMBIOSIS CORP.
8600 N.W. 41 ST.
MIAMI,  FL  33166
Applicant Contact KEVIN W SMITH
Correspondent
SYMBIOSIS CORP.
8600 N.W. 41 ST.
MIAMI,  FL  33166
Correspondent Contact KEVIN W SMITH
Regulation Number876.4300
Classification Product Code
KGE  
Subsequent Product Code
KNW  
Date Received04/20/1993
Decision Date 03/15/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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